# K172986: Zmachine Synergy

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Research of Richmond, Inc. Dba General Sleep CO
- Decided: Dec 19, 2017 after 83 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913396 (1992). 45 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101830: Zmachine, Model DT-100, Consolidated Research of Richmond, Inc. (2011) Summary page 4.
- K143272: ApneaLink Air, Resmed Germany, Inc. (2015) Summary page 4.

## Most influential descendants
- K242447: Falcon HST (2025), 0 descendants of its own
- K192624: ApneaTrak (2020), 0 descendants of its own

## Indications for use
The Zmachine Synergy is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

Source page: https://510kreport.com/device/K172986
Methodology: https://510kreport.com/methodology